曲妥珠单抗双规格(150 mg+60 mg)组合治疗人表皮生长因子受体2阳性乳腺癌的临床综合评价

Clinical Comprehensive Evaluation of Two Specifications Trastuzumab(150 mg+60 mg)Combination in the Treatment of HER2-positive Breast Cancer

目的评价曲妥珠单抗双规格(150 mg+60 mg)组合治疗人表皮生长因子受体2(HER2)阳性乳腺癌的临床综合价值。方法运用文献调研、专家咨询的方法构建临床综合评价框架及指标,结合系统评价、临床试验数据、真实世界研究、药品说明书等资料,采取定性定量相结合的方式分析曲妥珠单抗双规格组合的有效性、安全性、经济性、适宜性、可及性、创新性。结果各项临床试验结果显示,曲妥珠单抗生物类似药与原研曲妥珠单抗具有相似的安全性、有效性;由于150 mg与60 mg的曲妥珠单抗上市时间较晚,其可获得性较差;曲妥珠单抗150 mg、440 mg单独使用且余液不留用的周期治疗费用分别为77648元、82500元,曲妥珠单抗双规格组合使用为64869.34元,更具有经济性;就可负担性而言,曲妥珠单抗双规格组合>原研曲妥珠单抗余液储存>HLX02(150 mg)>原研曲妥珠单抗余液浪费;并且双规格组合使用具有一定的临床使用创新性。结论曲妥珠单抗双规格(150 mg+60 mg)组合具有较好的临床价值,可为临床合理用药、国家相关药品目录遴选提供相关参考。

Objective To analyze and evaluate the Clinical comprehensive evaluation of two specifications trastuzumab(150 mg+60 mg)combination in the treatment of HER2-positive breast cancer.Methods Literature research and expert consultation methods were used to construct a comprehensive clinical evaluation framework and indicators,and combined with systematic reviews,clinical trial data,real-world studies,drug instructions and other information,a qualitative and quantitative approach was used to analyze the two specifications trastuzumab(150 mg+60 mg)combination of effectiveness,safety,economy,suitability,accessibility and innovation.Results The results of various clinical trials show that trastuzumab biosimilars have similar safety and effectiveness to the trastuzumab.Due to the late launch of trastuzumab 150 mg and 60 mg,their availability is poor.The cycle treatment costs of trastuzumab 150 mg and 440 mg alone without any remaining fluid are 77,648 yuan and 82,500 yuan respectively.The cost of two specifications trastuzumab combination is 64,869.34 yuan,which is more economical.In terms of affordability,combination of two specifications of trastuzumab>trastuzumab storage>HLX02(150 mg)>trastuzumab waste;and the use of dual-strength combination has certain limitations Clinical use innovation.Conclusion The combination of two specifications of trastuzumab(150 mg+60 mg)has good clinical value and can provide relevant reference for rational clinical drug use and selection of relevant national drug catalogs.